Key Responsibilities

• 
  Lead and execute
  electrical design verification testing (DVT)
  activities for implantable and external medical devices.
• 
  Develop and document
  test protocols, test plans, and verification procedures
  in compliance with quality and regulatory standards.
• 
  Perform
  bench testing
  using standard electrical engineering laboratory equipment (oscilloscopes, multimeters, function generators, etc.).
• 
  Analyze and interpret test data; summarize findings and provide clear technical documentation.
• 
  Coordinate and track
  test investigations
  , ensuring timely completion and documentation accuracy.
• 
  Lead or support
  failure analysis and root cause investigations
  for test nonconformances and component issues.
• 
  Work closely with
  R&D, Quality, Manufacturing, and Systems Engineering
  teams to resolve technical challenges and ensure design robustness.
• 
  Support
  yield improvement activities
  , identifying and implementing process or design enhancements.
• 
  Maintain strict adherence to
  design control and quality system requirements
  , ensuring full traceability and compliance with
  FDA, ISO 13485, and IEC standards
  .

Must-Have Qualifications

• 
  Bachelor’s degree in Electrical Engineering
  or related discipline
  with professional experience in
  electrical engineering in
  medical device product development
  or a highly regulated industry.
• 
  Proven experience in the
  DVT phase
  of product development and transition to manufacturing.
• 
  Strong background in
  data analysis
  using
  Minitab, JMP, or Microsoft Excel
  .
• 
  Demonstrated ability to lead and close projects involving
  cross-functional collaboration
  .
• 
  Experience performing
  bench-level testing and troubleshooting
  using standard EE test instruments.
• 
  Excellent
  technical documentation, communication, and problem-solving
  skills.
• 
  Proven ability to manage multiple priorities while maintaining attention to detail and compliance.

Preferred Qualifications

• 
  Experience with
  active implantable or Class III medical devices
  .
• 
  Knowledge of
  IEC 60601
  ,
  ISO 14708
  , and
  FDA Design Control (21 CFR 820.30)
  standards.
• 
  Familiarity with
  SPICE simulation tools
  ,
  PCB design and layout
  , or
  circuit debugging
  .
• 
  Experience with
  root cause analysis, FMEA, and CAPA methodologies
  .
• 
  Demonstrated success in
  yield improvement initiatives
  and process optimization.